Open-Label Safety and Tolerability of Oxymorphone IR and ER in Opioid Tolerant Pediatric Subjects
Status:
Terminated
Trial end date:
2010-02-22
Target enrollment:
Participant gender:
Summary
Patients will convert from current opioid to Oxymorphone ER and undergo titration. During the
Titration Period, subjects will receive daily oxymorphone Extended Release tablets(s) every
12 hours. Dosing adjustments will be based on the review of the subject's pain scores.
Oxymorphone IR 5 mg will be provided to be used as supplemental "breakthrough" pain
medication (as needed). Titration Period will end when the fixed dose of study medication is
tolerated and the subject achieves adequate analgesia. Subjects will then proceed to the
open-label 3-month maintenance period on the fixed dose of study medication established
during the Titration Period.